EP1824540B1

EP1824540B1 - Perfected retractable needle safety syringe

Info

Publication number: EP1824540B1
Application number: EP05812866A
Authority: EP
Inventors: Isidoro Mazzara
Original assignee: Individual
Current assignee: Individual
Priority date: 2004-11-24
Filing date: 2005-11-24
Publication date: 2013-03-27
Anticipated expiration: 2025-11-24
Also published as: ITBS20040143A1; PL1824540T3; EP1824540A1; WO2006057025A1; US20080033355A1; ES2417066T3; US7717876B2

Description

The object of the present invention is a retractable needle safety syringe to prevent further use of the syringe after a first use.
Retractable needle syringes are already known from former patents by the owner of the present application.
One of them is disclosed in the patent no. 1.248.456 and another one in patent no. 1.288.237 . Another example of a retractable needle syringe is disclosed in DE 43 14 395 C1 .
The solutions described in these patents, however, exhibit construction and structural problems that make their construction particularly complex and expensive and, above all, do not always ensure a safe and regular operation due to such complexity.
The object of the present invention is to propose a retractable needle safety syringe which should exhibit a simpler and more rational construction by the use of functional devices which, even if simple from the construction point of view, should increase the safety of use.
Such object is achieved with a retractable needle safety syringe according to claim 1.
Further details of the invention will appear more evident from the following description of a preferred embodiment, made by way of an indicative non-limiting example with reference to the annexed drawing, wherein:
Figure 1 shows an axial section view of the syringe according to the invention in the condition immediately prior to its use;
Figure 2 shows the syringe after use;
Figure 3 shows a section view of an enlarged detail of the syringe head in the condition shown in Figure 1;
Figure 4 shows a section view of an enlarged detail of the syringe head in the condition shown in Figure 2;
Figure 5 shows a section view of an enlarged detail of the syringe head in the condition that allows the needle retraction; and
Figure 6 shows a section view of an enlarged detail of the syringe head in the needle retraction step.
Said drawing shows a syringe comprising a hollow cylinder 10, a needle holder 11, a needle 12 and a piston 13 with an operating stem 14.
The hollow cylinder 10 exhibits at the back, that is, at the end opposite needle 12, a gripping flange 10' and at the front it ends with a collar 10" inside which there is suitably seated the needle holder 11 integral with needle 12. The needle holder 11 exhibits an end portion 15 facing the interior of the hollow cylinder 10 and intended for allowing the retraction thereof, as explained hereinafter. It should be noted that the hollow cylinder 10 exhibits an increase of the internal diameter in the end portion thereof facing the needle holder 11. This allows both a proper suction and the full compression of the substance to be injected. Moreover, as described hereinafter, this increase of internal diameter aids the proper coupling of the needle holder 11.
Advantageously, needle 12 is secured to the needle holder 11 by gluing. For example, the latter exhibits a flared tip 11' which aids the introduction of needle 12 from the outside and which is then filled with a suitable amount of glue 44.
The operating stem 14 further exhibits an axial hole 16 in whose end portion facing the needle holder 11 there is seated an extractor element 17 connected to a retraction pre-loaded spring 18. Said spring 18 thus tends to pull the extractor element inside the axial hole 16 of the operating stem 14.
According to a preferred embodiment, spring 18 is a cylindrical helical spring and at the end opposite the extractor element, it is connected to a cap 40 that closes piston 13 at the back.
The extractor is held in position inside the end portion of stem 14 thanks to an annular tooth 23' obtained in said stem 14. Tooth 23' forms an abutment for an annular projection 33 obtained in the extractor element 17.
Advantageously, tooth 23' joints with the inner wall of stem 14 by an inclined plane 23" facing the annular projection 33.
Preferably, moreover, tooth 23' defines, together with a shoulder 21' obtained in stem 14, a lowered zone 32 wherein the annular projection 33 of the extractor element 17 is free to axially slide.
In other words, stem 14 pulls the extractor element 17 in the axial movements thereof inside the hollow cylinder 10 in both directions.
The extractor element 17 exhibits, in the portion thereof facing the needle holder 11, a recess or seat 19 intended for interacting with the end portion 15 of the needle holder 11, connecting with it after the syringe has been used.
More in detail, said recess 19 exhibits an undercut 19' and a seating aperture 19".
Piston 13, moreover, is associated to a sealing element 24 cooperating with the inner wall of the hollow cylinder 10.
According to a particularly advantageous embodiment, said sealing element is a simple o-ring. Preferably, said o-ring 24 is mounted about a portion of the extractor element 17 protruding from the axial hole 16 into stem 14. Advantageously, an annular groove 24' for seating o-ring 24 is obtained in said extractor element 17. It should be noted that the compression of o-ring 24 between the inner wall of the hollow cylinder 10 and the extractor element 17 determines a calibrated interference suitable for allowing o-ring 24 to always remain constrained to piston 13 also during the axial movements thereof in both directions.
Needle holder 11 is normally axially constrained to collar 10" thanks to the interaction between a tooth 20 that extends from the inner surface of said collar 10" and a corresponding recess 21 obtained in needle holder 11.
Said needle holder 11 further exhibits at least one slot 22 such as to impart radial elasticity to the end portion 15 of needle holder 11. Said slot 22 is necessary for the substance to be injected to easily flow through the needle without generating considerable hydrostatic pressures such as to decrease the elasticity of needle holder 11.
In turn, the end portion 15 exhibits a substantially truncated cone shape with a step or undercut 23, said end portion 15 and said step 23 being intended for seating and engaging with recess 19 provided on extractor 17.
According to a preferred embodiment, the front bottom wall of the hollow cylinder 10 exhibits a flat abutment portion 41 for the extractor element 17 and a substantially semi-cylindrical annular seat 42 suitable for receiving o-ring 24 when piston 13 reaches the advanced stroke end portion.
The operation of the syringe is clearly shown in Figures 3-6.
Figure 3 shows the condition immediately prior to the use of the syringe, wherein extractor 17 has not reached the end of stroke.
The condition shown in Figure 4 describes the moment when stem 14 has reached the useful stroke end. Extractor 17 is pushed forward so that the end portion 15 of needle holder 11 seats into recess 19 after the deformation thereof, elastically obtained due to the presence of slots 22 and so that it remains constrained thereto thanks to the interaction between step 23 and undercut 19'.
Thanks to the compressibility of the sealing element 24, it is then possible to further push stem 14 forward relative to the extractor element 17 so that tooth 23' of stem 14 goes beyond the annular projection 33 of the extractor element 17. The latter is then free to retract into the axial hole 16 pulled by the return spring 18. The force of said spring 18 is selected so as to overcome the coupling between tooth 20 of needle holder 11 and recess 21 of collar 10", so that the extractor element 17 pulls the needle holder 11 inside the syringe.
It should be noted that the increase of the inner diameter of the hollow cylinder 10 in the end portion thereof allows the sealing element 24 to radially expand when pressed by stem 14, thus allowing the further advance of the latter, as shown in Figure 5.
On the other hand, the compression of the sealing element 24 by the operating stem 14 becomes necessary to contrast the increase of pressure of the fluid to be injected that occurs as piston 13 approaches the stroke end position.
In other words, the configuration and combination of extractor element, operating stem, sealing element and inner surface of the hollow cylinder, when the piston reaches the front stroke end position, make the residual fluid into the syringe to be considerably below the value imposed by the standards on the field.
The retractable needle safety syringe described above exhibits a particularly simple and therefore reliable structure. The needle retractable characteristic, in fact, uses the elasticity of the sealing element 24 and a suitable calibration of the force of the return spring 18 relative to the interferences between stem 14 and extractor element 17 and between needle holder 11 and collar 10".
In fact, the interference between tooth 23' of stem 14 and projection 33 of the extractor element must be such as to overcome the spring force to normally block the extractor element in advanced position, but at the same time it must allow the further advance of the stem relative to the extractor element when the latter is in stroke end position.
On the other hand, the force of spring 18 must be such as to overcome the interference between tooth 20 of collar 10" and annular recess 21 of needle holder 11.
It should be noted that the use of a conventional o-ring 24, in place of the special rubber caps to be fitted on the end of the syringe piston stem, besides considerably reducing the manufacturing cost of the syringe, favours the automated assembly of the syringe itself, since it allows using the high elasticity of the o-ring and its easiness in being handled by automated assembly machines.
The syringe proposed herein is also especially safe in its regular use. This is especially due to the needle gluing to the needle holder, and to the connection thereof to the syringe cylinder collar. The needle gluing, which among the other things is also advantageously introduced into the needle holder from the outside, rather than being forced, that is, with interference, into the needle holder, allows preventing the risk of any scraping of the needle holder which could cause the suction of air which must then be ejected before the injection. The glued needle further offers a considerably higher resistance to penetration and to the following extraction than that required by the standards of the field.
Also the connection of the needle holder to the cylinder collar described herein offers, as compared to the conventional connection by interference, a higher resistance to retraction, in any case higher than the values required by the standards.
Although the present invention has been described with respect to a number of embodiments, those embodiments are ment to be illustrative, rather than limiting. As those of ordinary skill in the art will understand, modifications and variations to the retractable needle syringe according to the present invention are possible within the scope of the appended claims.

Claims

A perfected retractable needle safety syringe comprising a hollow cylinder (10), a needle holder (11) at an end of said hollow cylinder, a needle (12) fixed to said needle holder, a piston (13) with an operating stem (14) sliding in said hollow cylinder, wherein the piston is associated to a sealing element (24) cooperating with 0 the inner wall of the hollow cylinder (10), wherein said stem exhibits an axial hole (16) wherein there is seated an extractor element (17) having an end portion protruding from said axial hole and suitable for connecting to said needle holder (11), wherein said extractor element is connected to a retraction pre/loaded spring (18), and wherein said extractor element (17) is held in position inside the end portion of stem (14) against the force exerted by the retraction pre-load spring thanks to an annular tooth (23') obtained in said stem (14) and forming an abutment for an annular projection (33) obtained in the extractor element (17) characterised in that said sealing element (24) is a conventional o-ring fitted on said end portion of the extractor element (17) protruding from said axial hole in such a way to be compressed by the operating stem against said end of the hollow cylinder when the extractor element is in the stroke end position connected to the needle holder, said compression of the o-ring allowing a further advance of the operating stem (14) relative to the extractor element (17) so that the tooth (23') of the operating stem (14) goes beyond the annular projection (33) of the extractor element (17), thus allowing the retraction of the extractor element with the connected needle holder (11) into the axial hole (16) of the operating stem (14).
A syringe according to claim 1, wherein the hollow cylinder (10) exhibits an increase of the internal diameter in the end portion thereof facing the needle holder (11) so as to allows the o-ring (24) to radially expand when pressed by the operating stem (14).
A syringe according to claim 1 or 2, wherein the bottom wall of said cylinder end exhibits a substantially semi-cylindrical annular seat (42) suitable for receiving said o-ring (24) when compressed by the operating stem (14).
A syringe according to any one of the previous claims, wherein in said end portion of the extractor element (17) there is obtained an annular groove (24') for seating said o-ring (24).
A syringe according to any one of the previous claims 7. wherein said tooth (23') of the operating stem defines, together with a shoulder obtained in said stem, a lowered zone (32) wherein the annular projection (33) of the extractor element is free to axially slide.
A syringe according to any one of the previous claims, wherein said extractor element (17) exhibits, in the portion thereof facing the needle holder (11), a seat or recess (19) intended for connecting with an end portion (15) of said needle holder (11).
A syringe according to claim 6, wherein said recess (19) exhibits an undercut (19') and a seating aperture (19").
A syringe according to claim 7, wherein said end portion (15) of the needle holder (11) exhibits a substantially truncated cone shape with a step or undercut (23), said end portion being intended for seating into said recess of the extractor element, said step being suitable for engaging in said undercut (19') of said recess (19).
A syringe according to any one of the previous claims, wherein the needle holder (11) is normally inserted in a collar (10") that extends from said end of the hollow cylinder (10) and is axially constrained to said collar thanks to the interaction between a tooth (20) that extends from the inner surface of said collar and a corresponding recess (21) obtained in the needle holder (11).
A syringe according to claim 9, wherein said needle holder (11) further exhibits at least one slot (22) such as to impart radial elasticity to said end portion (15) of the needle holder.
A syringe according to any one of the previous claims, wherein the needle is secured to the needle holder by gluing.
A syringe according to claim 11, wherein the needle holder (11) exhibits a flared tip (11') suitable for aiding the introduction of the needle from the outside and for being then filled with a suitable amount of glue.